LICENSE AND COLLABORATION AGREEMENT

EXHIBIT 10.12

LICENSE AND COLLABORATION AGREEMENT

     License and Collaboration Agreement (this “Agreement”) made as of June 2, 2005, by and between Acuity Pharmaceuticals, Inc., a Delaware corporation, with its principal offices at 3701 Market Street, Philadelphia, PA, 19104 (“ Acuity ”) and Intradigm Corporation with its principal offices at 12115 Parklawn Drive, Suite K, Rockville, MD 20852 (“ Intradigm ”), (Acuity and Intradigm are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties ”).

BACKGROUND

     WHEREAS, Intradigm is an RNAi delivery technology company, with proprietary technology and expertise in drug delivery;

     WHEREAS, Intradigm has developed formulation and drug delivery technology with commercial promise for formulation of oligonucleotides to enhance and aid in delivery to desired target tissues that may be applicable to the development of ophthalmic therapeutics that can be delivered less invasively than intra-ocular injection, such as topical application.

     WHEREAS, Acuity has proprietary technology and expertise in the area of ophthalmic pharmaceutical clinical development;

     WHEREAS, Acuity and Intradigm share a mutual interest in a collaboration aimed at the further development and commercialization of a therapeutic encompassing or employing a short interfering RNA (an “ siRNA ”) that is deliverable to the posterior pole of the eye which may be administered by topical application for pharmaceutical use in humans (the “ Topical siRNA ”); and

     WHEREAS, Acuity and Intradigm intend to utilize their capabilities, capitalize on each other’s expertise, and put forth commercially reasonable efforts to achieve the objectives of this collaboration.

     NOW, THEREFORE, in consideration of the mutual promises, covenants, agreements, representations and warranties hereinafter set forth, and intending to be legally bound, the Parties hereby agree as follows:

ARTICLE I
DEFINITIONS

      “Acuity Improvements” means any improvements to the Acuity Patent Rights and Acuity Know-how, in each case owned by Acuity as of the date hereof, that are conceived, created, developed, and/or otherwise invented by Acuity, by Intradigm, or jointly by Acuity and Intradigm, under the Research and Development Plan or pursuant to this Agreement.

      “Acuity Intellectual Property ” means the Acuity Patent Rights, Acuity Improvements, and the Acuity Know-how.

      “Acuity Know-how” means Technical Information owned, developed, or controlled by Acuity (other than as a result of this Agreement) as of the date of this Agreement or during the Term of this Agreement.

      “Acuity Patent Rights” means any valid claim of any Patent issued based on a patent application previously or hereafter filed by or on behalf of Acuity or subsequently assigned, licensed, or granted to, or acquired by, Acuity (other than pursuant to this Agreement), including without limitation Patents and patent applications based on Acuity Improvements.

      “Affiliate” means any entity that directly or indirectly Owns, is Owned by, or is under common Ownership with a Party to this Agreement. “Owns” or “Ownership” means direct or indirect possession of more than fifty percent (50%) of the votes of holders of a corporation’s voting securities or a comparable equity interest in any other type of entity.

      “Agency” means the FDA or any governmental regulatory authority responsible for granting approvals for the sale of the Topical siRNA in the United States or any foreign country.

      “Agreement” means this Agreement, together with all exhibits and attachments.

      “Clinical Trials” means all trials and studies of the application of the Topical siRNA on humans or clinical studies performed by Acuity for any purpose including without limitation for purposes of obtaining Regulatory Approval in the United States or any foreign country and marketing of the Topical siRNA in the United States or any foreign country.

      “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party with respect to any objective, diligent, good faith efforts to accomplish such objective as such Party would normally use to accomplish a similar objective under similar circumstances, it being understood and agreed that with respect to the development and commercialization of Topical siRNA, such efforts shall be substantially equivalent to those efforts and resources commonly used by a bio-pharmaceutical company for a similar pharmaceutical product owned by it or to which it has rights, which product is at a similar stage in its development or product life and is of similar market potential taking into account efficacy, safety, approved labeling, the competitiveness of alternative products in the marketplace, the patent and other proprietary position of the product, the likelihood of regulatory approval given the regulatory structure involved, the profitability of the product including the royalties payable to Third Parties, alternative products and other relevant factors. In evaluating profit potential or strategic value Acuity shall not consider the payments required to be made to Intradigm under this Agreement.

      “Confidential Information” has the meaning set forth in Section 9.1.

      “Control” means, with respect to an item of information or intellectual property right, the possession of the ability to grant a license or sublicense as provided for herein under such item or right without violating the terms of any agreement or other arrangement, express or implied, with any Third Party.

     “ Critical Field of Use ” means the treatment of ophthalmic diseases characterized by excessive or unwanted neovasculature, angiogenesis or leakage such as but not limited to Wet AMD, diabetic retinopathy, diabetic macular edema, retinal vein occlusion, neovascular

glaucoma, retinopathy of prematurity, Von Hippel Angioma, von-hippel landau, Corneal Neovascularization, Rubeosis, Pterygium or Iris Neovascularization as well as, dry AMD, drusen and uveitis.

     “ Effective Date ” means the day and year first indicated above.

     “ Excluded Field of Use ” means the treatment of ophthalmic diseases in the Critical Field of Use or Non-Critical Field of Use (other than through the use of the Topical siRNA) in which a drug is delivered through systemic administration only (and not through, in whole or in part, topical application, ocular injection or any other method).

     “ Excluded Territory ” means China, Hong Kong, Taiwan, Japan, Korea, Singapore, Thailand, Indonesia, Malaysia, Australia and New Zealand.

      “FDA” means the United States Food and Drug Administration, or any successor thereto.

      “Fiscal Quarter” means each period of three (3) months ending on March 31, June 30, September 30, or December 31.

      “GAAP” means generally accepted accounting principles as in effect from time to time in the United States.

     “ IND ” means an “investigational new drug application” as defined by the United States Food, Drug, and Cosmetic Act, as amended (the “Act”), and applicable FDA rules and regulations or a foreign equivalent.

      “Intradigm Improvements” means any improvements to the Intradigm Patent Rights and Intradigm Know-how, in each case owned by Intradigm as of the date hereof, that are conceived, created, developed, and/or otherwise invented by Intradigm, by Acuity, or jointly by Intradigm and Acuity, under the Research and Development Plan or pursuant to this Agreement.

      “Intradigm Intellectual Property” means the Intradigm Patent Rights, Intradigm Improvements, and the Intradigm Know-how.

      “Intradigm Know-how” means Technical Information owned, developed, or controlled by Intradigm as of the date of this Agreement or during the Term of this Agreement.

      “Intradigm Novel siRNA Target ” means a gene or mRNA that could be targeted with siRNA identified in the Intradigm Patent Rights, where the gene or mRNA has not previously been described in the literature or otherwise known to Acuity.

      “Intradigm Patent Rights” means any valid claim of any Patent issued based on a patent application previously or hereafter filed by or on behalf of Intradigm or subsequently assigned, licensed, or granted to, or acquired by, Intradigm, including without limitation Patents and patent applications based on Intradigm Improvements. Exhibit A lists all the patents and patent applications giving rise to Intradigm Patent Rights as of the date of this Agreement.

     “ Intradigm Sublicensed Products ” means Licensed Products (other than the Topical siRNA) that are sold by a Third Party under a sublicense from Acuity for which Acuity would be required to pay a royalty to Intradigm pursuant to Section 7.4 of this Agreement, if such product were sold by Acuity or its Affiliates.

     “ Jointly-Owned Intellectual Property ” means developments, discoveries, inventions, ideas, processes, methods, compositions, formulae, techniques, information and data, whether or not patentable, conceived, developed or reduced to practice jointly by one or more employees of Acuity on the one hand and one or more employees of Intradigm on the other hand in connection with the research and development activities performed pursuant to this Agreement which are not Intradigm Improvements or Acuity Improvements.

      “Launch” means the date of first commercial shipment of the Topical siRNA by Acuity, its Affiliates, distributors, or sublicensees to Third Party customers in the United States or any foreign country after receipt of Regulatory Approval for the Topical siRNA from the FDA or other relevant Agency, as may be necessary in such country.

     “ Licensed Products ” means products whose manufacture, use or sale would, but for the existence of this Agreement, infringe a valid claim of the Intradigm Patent Rights.

      “NDA” means a “new drug application,” as defined in the Act and applicable FDA rules and regulations, including an application of the type described in section 505(b)(2) of the Act.

      “Net Sales” means the total gross proceeds to Acuity on sales to Third Parties representing sales actually collected by Acuity and its Affiliates, less deductions for the following to the extent actually paid or allowed with respect to the such sales:

          (a) sales and excise taxes and duties (including import duties) paid or allowed by a selling party and any other governmental charges imposed upon the manufacture or sale, after giving effect to any rebates or refunds relating to such taxes or duties received by Acuity;

          (b) rebates and chargebacks (including rebates to social and welfare systems) actually paid;

          (c) allowances, chargebacks, and credits to Third Parties on account of rejected, damaged, outdated, returned, withdrawn, or recalled product or on account of retroactive price reductions affecting such product; and

          (d) amounts paid to Third Parties on account of rebate payments, including Medicaid rebates.

     Taxes, the legal incidence of which is on the purchaser and separately shown on Acuity’s or its Affiliates’ invoices, and transportation, insurance and postage charges, if prepaid by Acuity or its Affiliates and billed on Acuity’s or its Affiliates’ invoices as a separate item, shall not be considered a component of Net Sales. Components of Net Sales shall be determined in the ordinary course of business in accordance with Acuity’s historical practice and using the accrual method of accounting in accordance with GAAP.

     The supply of a product as commercial samples or for use in clinical trials or studies shall not be included within the computation of Net Sales.

     Where (i) a product is sold by Acuity or an Affiliate as one of a number of items without a separate price; or (ii) the consideration for a product shall include any non-cash element; or (iii) the product is transferred by Acuity or an Affiliate in any manner other than an invoiced sale, the Net Sales price applicable to any such transaction shall be deemed to be Acuity’s average Net Sales price for the applicable quantity of a product to the relevant class of customers at that time.

     “ Net Sublicense Payments ” means (a) cash payments made to Acuity in consideration of the sublicense; and (b) the fair market value of any non-cash consideration received by Acuity from a sublicense in consideration of the sublicense other than; provided, however that the following shall not be included in the calculation of Net Sublicense Payments (i) reasonable amounts received in exchange for equity investments in Acuity by a sublicensee, (ii) sponsored research funding paid to Acuity by a sublicensee in a bona fide transaction for future research to be performed by Acuity; (iii) payments for consulting services actually performed by Acuity in a bona fide transaction at arms length rates; and (iv) intellectual property rights received by Acuity from a sublicensee, including, but not limited to, licenses or sublicenses to intellectual property rights, covenants not to compete against Acuity, or agreements not to assert claims against Acuity.

     “ Non-Critical Field of Use ” means the treatment of any and all ophthalmic disease, other than those included in the Critical Field of Use.

      “Patents” means all valid claims in all patent applications, and all foreign patents and patent applications based thereon, including any continuations, divisionals, continuations-in-part, extensions, reissues and re-examinations of any of the foregoing and all patents issuing from any of the foregoing applications.

     “ Product Success Criteria ” means, with respect to the Topical siRNA, those criteria agreed between the Parties and to be set forth in the Research and Development Plan.

      “Regulatory Approval” means the Topical siRNA license or marketing approval necessary as a prerequisite for marketing the Topical siRNA in the United States or any foreign country.

      “Research and Development Plan” means the development program for the Topical siRNA as described in Section 4.1 hereof which shall be agreed upon by the Parties within 30 days of the date of this Agreement.

      “Technical Information” means all techniques and data and other know-how and technical information, including inventions (including patentable inventions), practices, methods, concepts, know-how, trade secrets, documents, computer data, source code, apparatus, clinical and regulatory strategies and data, test data, analytical and quality control data, manufacturing data or descriptions, development information, drawings, specifications, designs, plans, proposals and technical data and manuals and all other proprietary information concerning the development, manufacture, production, quality control, storage, distribution and sale of Licensed Products or the Topical siRNA.

      “Third Party” means any entity other than Intradigm or Acuity or their Affiliates.

ARTICLE II
OWNERSHIP OF INTELLECTUAL PROPERTY; LICENSE GRANTS

      2.1. Ownership of Inventions .

               (a) Except as provided in this Article II, Intradigm shall own all right, title, and interest in and to the Intradigm Intellectual Property and Acuity shall assign any rights it may have in such Intradigm Improvements to Intradigm. Acuity shall own all right, title, and interest in and to the Acuity Intellectual Property and Intradigm shall assign any rights it may have in such Acuity Improvements to Acuity.

               (b) Any Intradigm Improvements conceived or reduced to practice during the Term shall become the property of Intradigm, whether conceived or reduced to practice by or on behalf of Acuity and Acuity shall assign any rights it may have in such Intradigm Improvements to Intradigm.

               (c) Any Acuity Improvements conceived or reduced to practice during the Term shall become the property of Acuity, whether conceived or reduced to practice by or on behalf of Intradigm and Intradigm shall assign any rights it may have in such Acuity Improvements to Acuity.

               (d) Jointly-Owned Intellectual Property shall be owned jointly by Acuity and Intradigm.

      2.2. License Grants to Acuity.

               (a) Intradigm hereby grants to Acuity, and Acuity hereby accepts from Intradigm, a sole and exclusive (even as to Intradigm) irrevocable right and license, including the right to sublicense, under and to Intradigm Intellectual Property to make, have made, use, sell, offer for sale, import or otherwise commercialize Licensed Products in the Critical Field of Use.

               (b) Intradigm hereby grants to Acuity, and Acuity hereby accepts from Intradigm, a sole and exclusive (even as to Intradigm) irrevocable right and license, including the right to sublicense, under and to Jointly-Owned Intellectual Property to make, have made, use, sell, offer for sale, import or otherwise commercialize Topical siRNA and Licensed Products in the Critical Field of Use and the Non-Critical Field of Use.

      2.3. Revocable License Grant to Acuity.

               (a) Intradigm hereby grants to Acuity, and Acuity hereby accepts from Intradigm, a sole and exclusive (even as to Intradigm), revocable in part (pursuant only to Section 2.3(b) and (c)) right and license, including the right to sublicense, under and to Intradigm Intellectual Property to make, have made, use, sell, offer for sale, import or otherwise commercialize Licensed Products in the Non-Critical Field of Use.

               (b) After February 1, 2007, Intradigm may notify Acuity that Intradigm intends (by itself or with a partner) to commercialize a therapeutic in the Non-Critical Field of Use which is not then being pursued by Acuity (the “ Optioned Therapeutic ”). Intradigm shall be required to include with such notification sufficient documentation to demonstrate to Acuity (through means reasonably acceptable to Acuity) that Intradigm is financially and technologically capable of commercializing the Optioned Therapeutic.

                    (i) Upon receipt of such notification and upon Acuity’s acknowledgment (which shall not be unreasonably withheld) that Intradigm is capable of such commercialization, Acuity shall have 120 days from such notification to provide Intradigm with a development plan demonstrating Acuity’s financial and technical ability (including Acuity’s ownership of, or ability to obtain a license to, intellectual property which is required to commercialize the Optioned Therapeutic) and intent to commercialize the Optioned Therapeutic.

                    (ii) At this time, if Acuity desires to commercialize the Optioned Therapeutic, Acuity will enter into a binding agreement with Intradigm that requires Acuity to expend a mutually agreed upon amount of capital to commercialize the Optioned Therapeutic over an agreed upon time period.

                    (iii) If Acuity (A) fails to notify Intradigm during this 120-day period of Acuity’s intent to, and reasonably demonstrates its financial and technological ability to, commercialize the Optioned Therapeutic or (B) Acuity materially breaches the agreement described in Section 2.3(b)(ii), Intradigm shall be free to pursue commercialization of the Optioned Therapeutic and the license granted by Intradigm to Acuity in Section 2.2(a) shall be revoked to the extent and only to the extent necessary for Intradigm to commercialize the Optioned Therapeutic.

      2.4. Revocable License Grant to Intradigm.

               (a) Acuity hereby grants to Intradigm, and Intradigm hereby accepts from Acuity, a sole and exclusive (even as to Acuity), revocable (pursuant only to Section 2.4(b)), royalty free, right and license, including the right to sublicense, under and to Intradigm Intellectual Property to make, have made, use, sell, offer for sale, import or otherwise commercialize Licensed Products in the Excluded Field of Use in the Excluded Territory.

               (b) If Intradigm fails to enter into a binding agreement to develop therapeutic products for the Excluded Field of Use in the Excluded Territory by December 31, 2005, the license granted by Acuity to Intradigm in Section 2.4(a) shall be terminated without any further action by Acuity or Intradigm.

      2.5. Maintenance of Records. Each Party shall maintain full and accurate records concerning their activities under this Agreement for the purpose of documenting any intellectual property developed hereunder. Such records shall be maintained for the later of either three (3) years after the end of the Term or for the pendency of any patent application covering any Jointly-Owned Intellectual Property.

ARTICLE III
OVERVIEW OF COLLABORATION

      3.1. Scope of Collaboration . The Parties shall work together to research and develop the Topical siRNA. All research and development work shall be conducted in accordance with a Research and Development Plan to be agreed upon by Acuity and Intradigm within thirty (30) days of the date of this Agreement (the “ Research and Development Plan ”).

      3.2. Additional Collaboration . The Parties shall exercise good-faith negotiations to enter into a separate collaboration aimed at the further development and commercialization of one or more therapeutics encompassing or employing an siRNA that is deliverable to the posterior pole of the eye which may be administered by systemic application for pharmaceutical use in humans (the “ Systemic siRNA ”). The financial terms of the Systemic siRNA collaboration shall be consistent with and substantially similar to the provisions of Sections 7.1, 7.3, 7.4, 7.5 and 7.6(a) of this Agreement, after taking into account and considering the relevant market for the Systemic siRNA and its expected commercial success.

      3.3. Recordkeeping . Each Party shall record, to the extent practical, all Technical Information relating to its research and development activities under the Research and Development Plan in written form, which writing shall be consistent with standard practices of each Party and what is normal and customary in the pharmaceutical industry in the United States or as may be required by applicable law or regulation. All such written records of the Parties shall be maintained in a form sufficient to satisfy all Agencies.

ARTICLE IV
RESEARCH AND DEVELOPMENT PROGRAM

      4.1. Research and Development Plan . The Research and Development Plan for the Topical siRNA, including tasks, allocation of responsibilities, estimated development timelines, and estimated development budgets, will be mutually agreed upon by Acuity and Intradigm within thirty (30) days of the date of this Agreement. The Research and Development Plan will also include the Product Success Criteria which will govern Acuity’s obligation to commercialize the Topical siRNA. The Parties may periodically modify the Research and Development Plan, within the scope of and in a manner consistent with this Agreement, further detail the responsibilities of each Party within the general scope of responsibilities set forth herein, each in accordance with Section 4.4. In the event that an estimated development timeline will not be met, the Party with responsibility for meeting that timeline shall notify the other Party and the Parties shall work together in good faith to bring the project back on schedule.

      4.2. Joint Development Committee .

               (b) The Development Program and all pre-clinical testing of the Topical siRNA shall be conducted under the direction of a joint development committee (the “ JDC ”). The JDC shall be composed of two (2) named representatives of Acuity and two (2) named representatives of Intradigm. The named representatives shall designate one member to serve as chairperson of the JDC. Each Party will identify its representatives to the JDC within

five (5) days after the date of this Agreement and each Party shall have the right to replace its representatives at any time in its sole discretion after giving notice to the other Party.

               (c) The purposes of the JDC shall be to review, direct, supervise and coordinate all operational and scientific aspects of the development of the Topical siRNA and all pre-clinical testing of the Topical siRNA (the “ Development Program ”). As part of its responsibilities, the JDC shall (i) within thirty (30) days of the Effective Date, finalize the terms of the Research and Development Plan, (ii) review the development of Intradigm under the Development Program, (iii) monitor the progress of the Development Program and evaluate the work performed and the results obtained in relation to the goals of the Development Program, (iv) approve any necessary or desirable modifications to, the Development Program and the Research and Development Plan, and (v) such other functions to which the Parties agree. The Party hosting each meeting of the JDC promptly shall prepare and deliver to the other Party within fifteen (15) business days after the date of such meeting, minutes of such meeting setting forth all decisions of the JDC relating to the Development Program in form and content reasonably acceptable to the other Party.

               (d) The JDC shall meet at least twice each quarter until the Development Program is completed (the “ Collaboration Term ”), at such times and places as agreed to by Intradigm and Acuity. The JDC and any of its members may meet or attend meetings by telephone or video conference. The JDC will communicate regularly by telephone, facsimile and video conference. Meetings and telephone and video conferences of the JDC may be attended by such other directors, officers, employees, consultants and other agents of Intradigm and Acuity as the Parties from time to time reasonably agree. Intradigm and Acuity will bear their own costs in attending such meetings.

               (e) The JDC will review the characteristics of the compounds identified under the Development Program, and the JDC will select the final compound or compounds which will be used for clinical testing.

               (f) All final decisions of the JDC shall be made by majority vote of all of the members.

      4.3. Joint Obligations .

               (a) Each Party agrees to commit the qualified and experienced personnel, facilities, equipment, expertise and other resources necessary to perform its obligations under this Agreement and the Research and Development Plan.

               (b) Except as set forth in Section 4.4, each Party will fund its own costs and expenses in the performance of its research and development obligations provided pursuant to this Agreement and the Research and Development Plan.

               (b) The Parties shall keep each other fully informed of the status of the development of the Topical siRNA including, without limitation, providing written reports as requested throughout the performance of the Research and Development Plan, stating in reasonable detail all efforts made and in process, and all significant progress achieved.

          (c) The Parties will each designate a primary project contact with respect to the Topical siRNA throughout the performance of the Research and Development Plan.

      4.4. Intradigm Obligations.

          (a) Intradigm shall use commercially reasonable efforts to diligently perform its obligations under this Agreement, including, without limitation, those to be set forth in the Research and Development Plan, all in accordance with all applicable laws, ordinances, rules, regulations, orders, licenses and other requirements now or hereafter in effect.

          (b) Intradigm shall be required to allocate one and one-half (1.5) FTEs (and no more) during the term of the Collaboration for the areas of activity set forth in the Research and Development Plan.

          (c) Intradigm shall make available to Acuity all Intradigm Intellectual Property and Technical Information and assistance as may reasonably be necessary for Acuity’s development, submission for applicable Regulatory Approval, and commercialization of the Topical siRNA, including formulation and process development, development of stability indicating methods (including methods for dissolution, assay and stability), and achievement of stability under accelerated stability conditions for two months or under ambient conditions for six months, stability data, methods validation, formulation trials, in-process and finished Products specifications, Product development reports for the Topical siRNA, and identification and sourcing of any excipients used in the formulation of the Topical siRNA, all as more particularly described herein and in the Research and Development Plan.

          (d) Intradigm shall maintain records in sufficient detail and otherwise in accordance with good laboratory practices or current good manufacturing practices, as the case may be, and as are required to properly reflect, and will document in a manner appropriate for purposes of supporting any Agency filings, and pre-approval inspections, all work done and results achieved by Intradigm in the performance of the Research and Development Plan (including all data in a form required under any applicable governmental regulations). Subject to the confidentiality provisions of Article X hereof, Intradigm shall provide Acuity with copies of all such records relating to the Topical siRNA.

      4.5. Acuity Obligations .

          (a) Acuity shall use Commercially Reasonable Efforts to diligently perform its obligations under this Agreement, including, without limitation, those set forth in the Research and Development Plan, all in accordance with all applicable laws, ordinances, rules, regulations, orders, licenses and other requirements now or hereafter in effect.

          (b) In consideration for Intradigm’s performance of its obligations under this Agreement and the Research and Development Plan, Acuity shall pay Intradigm $180,000 per year per FTE employed by Intradigm pursuant to Section 4.6(b).

          (c) Acuity shall maintain records in sufficient detail and otherwise in accordance with good laboratory practices, good clinical practices, or current good

manufacturing practices, as the case may be, and as are required to properly reflect, and will document all work done and results achieved in the performance of the Research and Development Plan including all records of any Clinical Trials. Subject to the confidentiality provisions of Article IX hereof, Acuity shall provide Intradigm with the right to inspect such records relating to the Topical siRNA.

          (d) Acuity shall keep Intradigm fully informed as to the continuing status of its Clinical Trials and development efforts for the Topical siRNA, including the status of the preparation and filing of any Regulatory Approvals with applicable Agencies as well as the anticipated Launch of the Topical siRNA and the status of the conduct and completion of Clinical Trials. In connection therewith, Acuity shall provide to Intradigm quarterly reports during the Term, stating in reasonable detail all efforts made and in process, and significant progress achieved. In addition, Acuity shall communicate to Intradigm any material issues or problems. Acuity shall include in such reports information concerning the status of the regulatory filings for the Topical siRNA and shall notify Intradigm of the substance of all material written communications with any Agencies relating to the Topical siRNA.

ARTICLE V
HEALTH REGISTRATION OBLIGATION

      5.1. Clinical Development; Regulatory Approvals . After the Topical siRNA compound is selected and approved by the JDC, Acuity shall use its Commercially Reasonable Efforts to prepare, file, and prosecute all Agency filings and applications to obtain all Regulatory Approvals for the Topical siRNA in the United States and any foreign country that Acuity chooses in its sole discretion, at Acuity’s sole expense. Acuity shall own all right, title, and interest in any FDA or other Regulatory Approvals which are obtained for the Topical siRNA, including all data generated in the course of Clinical Trials and all applications and data submitted to the FDA or other Agency.

      5.2. NDA . Acuity shall use Com